<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061081784574</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 13</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH369</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:39:44.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784567</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 12</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH368</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:36:45.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784550</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 11</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH367</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:33:32.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784543</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 10</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH366</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:32:14.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784536</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 9</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH365</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:29:49.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784529</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 8</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH364</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:27:15.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784512</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 7</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH363</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:26:23.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784505</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 6</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH362</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:22:32.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784499</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 5</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH361</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:17:27.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784482</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 4</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH360</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:15:41.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784475</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 3</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH359</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:13:38.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784468</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 2</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH358</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:11:18.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784451</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, 1</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH357</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:09:38.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784444</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, c4</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH356</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:08:03.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784437</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, c3</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH355</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:06:12.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784420</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, c2</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH354</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T11:01:52.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784413</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Medium, c1</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH353</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T10:59:29.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784406</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Small, 18</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH352</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T10:57:25.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784390</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Small, 17</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH351</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T10:55:04.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081784383</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX Cosmetic Hand, Men, Right, Small, 16</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCH350</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-07T10:51:20.535Z</lastUpdated>
  </row>
</eudamedExport>